Single Use Delivery Device Having a Primer Element

ABSTRACT

A single use delivery device is disclosed having a manually deformable liquid container defining an inner chamber, the container having a distal end, a body, a proximal end, and an outlet on the distal end; a tip projecting from the outlet on the distal end of the container, the tip in fluid communication with the inner chamber of the container; and a primer element for removing one or more air bubbles from the chamber, said primer element being attached to and in fluid communication with the deformable container. A method of administering a fluid to or flushing a vascular access device using a single use pre-filled delivery device as described herein is also disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority under 35 U.S.C. §119(e) to U.S.Provisional Application No. 61/664,456, filed Jun. 26, 2012, thedisclosures of which are incorporated herein by reference in theirentirety.

TECHNICAL FIELD

An aspect of the invention relates generally to a single use pre-filleddelivery device having a manually deformable liquid container definingan inner chamber, a tip projecting from the outlet on the distal end ofthe container, and a primer element for removing one or more air bubblesfrom the chamber. The container includes a distal end, a body, aproximal end, and an outlet on the distal end. The tip is in fluidcommunication with the inner chamber of the container. The primerelement is attached to and in fluid communication with the deformablecontainer. Another aspect of the invention relates generally to a methodof administering a fluid to or flushing a vascular access device usingthe single use pre-filled delivery device described herein.

BACKGROUND

Vascular access devices (VAD) used to access a patient's vascular spacewithout puncture using a hypodermic needle. Vascular Access Devices(VADs) include intravenous catheters, syringes, extension sets, stopcocks, tubing, high pressure extension tubing, and needleless accessdevices. These devices are used in patients where frequent access isrequired to the vascular space for delivery of treatment and withdraw offluids. Indwelling vascular access devices are susceptible to infectionand occlusion, requiring continued preventive maintenance. To ensureVADs are used properly and do not become occluded, standards of practicehave been developed to maintain the indwelling VAD. These standardsinclude a cleaning procedure, which is commonly referred to as a flushprocedure. One form of VAD maintenance is a continuous saline dip wherewhich a saline bag is connected to the VAD and provides continuous flowof saline solution to the patient through the VAD. This approach may putthe patient at risk by delivering excess fluid to the vascular space.

An alternative method for vascular device maintenance, known asflushing, involves intermittent delivery of saline thru the VAD using ahypodermic syringe. One way to deliver intermittent saline to the VAD isto fill a hypodermic syringe fitted with a needle from a saline vial orampoule. The filled syringe is then connected to the VAD and the salineis then flushed thru the VAD into the patient. Pre-filled deliverycontainers may be used to deliver sterile contents to a receivingconnection. Use of pre-filled saline flush syringes to deliver salineflush to VAD's offers improved safety and efficiency over manuallyfilled hypodermic syringes.

The containers may be formed using a variety of manufacturing processesincluding but not limited to extrusion molding, injection molding andblow fill seal molding. When a device is closed or sealed, however, aportion of the contained volume may be comprised of air. During use, itmay be necessary to remove the air within through a step known aspriming. The end result is a primed device where the internal surfacesof the device make contact with only the pre-filled solution and notair.

It is also important in the flush procedure not to draw blood back intothe catheter where it can clot and seal the catheter, commonly referredto as “reflux”. In order to prevent blood reflux into the catheter theuser is encouraged to maintain a positive pressure in the line duringthe flush procedure. This may involve clamping the IV line andwithdrawing the syringe and cannula from the IV port while stillapplying pressure to the syringe plunger rod during the flush procedure.When using a conventional syringe with an elastomeric stopper, thestopper is often compressed when it contacts the distal end of thesyringe barrel at the completion of the flush procedure. When a userrelieves the pressure to the plunger after the flush procedure iscompleted, the stopper will expand back to its normal size therebywithdrawing liquid from the catheter into the syringe barrel. This isundesirable, since it can cause blood to enter the catheter at thecatheter distal end (reflux) where it will remain stationary until thenext time the VAD is used.

Although a wide variety of catheters and I.V. ports can be adequatelyflushed using currently available syringe assemblies, as flushingpractices change from continuous IV drip to intermittent flushing, thereis a need for a new sterile, single use, pre-filled delivery device formaintenance of VAD's that reduces reflux while removing unwanted airfrom the delivery chamber of a closed pre-filled container.

SUMMARY

An embodiment of the present invention is directed to a single usedelivery device having a manually deformable liquid container definingan inner chamber, a tip projecting from the outlet on the distal end ofthe container, and a primer element for removing one or more air bubblesfrom the chamber. The container includes a distal end, a body, aproximal end, and an outlet on the distal end. The tip is in fluidcommunication with the inner chamber of the container and is releasablyengageable to a vascular access device. The vascular access device maybe a syringe, extension set, intravenous set, stop cock, tubing, highpressure extension tubing, or needleless connector.

The primer element is attached to and in fluid communication with thedeformable container. The primer element may be assembled into the bodyof the container or it may be molded into the body of the container. Theprimer element may be positioned on the proximal end of the container.

In one or more embodiments, the primer element may be in the form of acollapsible button which is convex prior to the primer being manuallydepressed and is concave after the primer is manually depressed.

In one or more embodiments, the primer element includes a thumb presslocated at the proximal end of the container and the body of thecontainer comprises a plurality of collapsible funnel-shaped,concentrically-arranged side walls, wherein the diameters of theconcentrically-arranged walls decrease from the distal end to theproximal end of the liquid container.

In an alternate embodiment, the primer element includes a thumb presslocated at the proximal end of the container and the body of thecontainer comprises a plurality of collapsible funnel-shaped,nonconcentrically-arranged side walls, wherein the diameters of thenonconcentrically-arranged walls decrease from the distal end to theproximal end of the liquid container.

In yet another embodiment, the primer element may be in the form of aseries of two or more adjoining collapsible buttons in fluidcommunication.

In one or more embodiments, the single use delivery device includes apre-selected amount of fluid in the chamber.

The deformable container may be made of thermoplastic elastomers.

Another embodiments of the present invention is directed to a method ofdelivery fluid to a vascular access device comprising providing a singleuse delivery device having a manually deformable liquid containerdefining an inner chamber, the container having a distal end, a body, aproximal end, and an outlet on the distal end; a tip projecting from theoutlet on the distal end of the container, the tip in fluidcommunication with the inner chamber of the container; and a primerelement for removing one or more air bubbles from the chamber, saidprimer element being attached to and in fluid communication with thedeformable container; providing a vascular access device having aproximal end, a distal end, and a passageway therethrough, the proximalend having a female luer tip in fluid communication with the passageway;placing the distal end of the vascular access device in a blood vesselof a patient; depressing the primer element to evacuate air within thechamber; engaging the male tip of the container with the female tip ofthe vascular access device; applying force to deform the container sothat a solution located in the chamber flows through the one-way valveinto the vascular access device; and disengaging the male tip of thecontainer from the female tip of the vascular access device.

An embodiments of the present invention is directed to a single usedelivery device including a manually deformable liquid containerdefining an inner chamber, the container having a distal end, a proximalend, and an outlet on the distal end; a tip projecting from the outleton the distal end of the container, the tip in fluid communication withthe inner chamber of the container; a primer element for collapsing aportion of the deformable container for driving air out of said chamberby depressing the primer element, said primer element being attached tothe deformable container; and a one-way valve disposed between the tipand the deformable container, the one-way valve in fluid communicationwith the inner chamber of the container, said one-way valve permittingair or fluid evacuation from the inner chamber but preventing air orfluid intake into the inner chamber when the container is manuallydeformed and released.

The one-way valve prevents reflux of solution in the passageway. Theone-way valve may be a duckbill valve, an umbrella valve, a ball-checkvalve, diaphragm check valve, swing check valve, stop-check valve,lift-check valve or a combination thereof.

Another aspect of the present invention pertains to a method of deliveryfluid to a vascular access device comprising providing a single usedelivery device having a manually deformable liquid container, a tipprojecting from an outlet on the distal end of the container and beingin fluid communication with the inner chamber of the container, a primerelement for collapsing a portion of the deformable container for drivingair out of said chamber by depressing the primer element, and a one-wayvalve disposed between the tip and the deformable container as describedherein; providing a vascular access device having a proximal end, adistal end, and a passageway therethrough, the proximal end having afemale luer tip in fluid communication with the passageway; placing thedistal end of the vascular access device in a blood vessel of a patient;depressing the primer element to evacuate air within the chamber;engaging the male luer connector of the container with the female luerof the vascular access device; applying force to deform the container sothat a solution located in the chamber flows through the one-way valveinto the vascular access device; and disengaging the male luer connectorof the container from the female luer of the vascular access device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view illustrating one embodiment of the singleuse pre-filled delivery device of the present invention.

FIG. 2 is a perspective view illustrating a second embodiment of thesingle use pre-filled delivery device of the present invention.

FIG. 3 is a perspective view illustrating a third embodiment of thesingle use pre-filled delivery device of the present invention.

FIG. 4 is a perspective view illustrating a third embodiment of thesingle use pre-filled delivery device of the present invention having atip cap.

FIG. 5 is a top view illustrating a third embodiment of the single usepre-filled delivery device of the present invention having a tip cap.

FIG. 6 is a side view illustrating a third embodiment of the single usepre-filled delivery device of the present invention having a tip cap.

FIG. 7 is a bottom view illustrating a third embodiment of the singleuse pre-filled delivery device of the present invention having a tipcap.

FIG. 8 is a side view illustrating a third embodiment of the single usepre-filled delivery device of the present invention having a tip cap.

FIG. 9 is a back view illustrating a third embodiment of the single usepre-filled delivery device of the present invention having a tip cap.

FIG. 10 is a front view illustrating a third embodiment of the singleuse pre-filled delivery device of the present invention having a tipcap.

FIG. 11 is a perspective view illustrating a third embodiment of thesingle use pre-filled delivery device of the present invention having atip cap.

FIG. 12 is a top view illustrating a third embodiment of the single usepre-filled delivery device of the present invention having a tip cap.

FIG. 13 is a side view illustrating a third embodiment of the single usepre-filled delivery device of the present invention having a tip cap.

FIG. 14 is a bottom view illustrating a third embodiment of the singleuse pre-filled delivery device of the present invention having a tipcap.

FIG. 15 is a side view illustrating a third embodiment of the single usepre-filled delivery device of the present invention having a tip cap.

FIG. 16 is a back view illustrating a third embodiment of the single usepre-filled delivery device of the present invention having a tip cap.

FIG. 17 is a front view illustrating a third embodiment of the singleuse pre-filled delivery device of the present invention having a tipcap.

FIGS. 18 and 19 are perspective views illustrating a fourth embodimentof the single use pre-filled delivery device of the present invention.

FIG. 20 is a top view illustrating a fourth embodiment of the single usepre-filled delivery device of the present invention.

FIG. 21 is a side view illustrating a fourth embodiment of the singleuse pre-filled delivery device of the present invention.

FIG. 22 is a bottom view illustrating a fourth embodiment of the singleuse pre-filled delivery device of the present invention.

FIG. 23 is a side view illustrating a fourth embodiment of the singleuse pre-filled delivery device of the present invention.

FIG. 24 is a front view illustrating a fourth embodiment of the singleuse pre-filled delivery device of the present invention.

FIG. 25 is a back view illustrating a fourth embodiment of the singleuse pre-filled delivery device of the present invention.

FIG. 26 is a perspective view illustrating a fifth embodiment of thesingle use pre-filled delivery device of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Before describing several exemplary embodiments of the invention, it isto be understood that the invention is not limited to the details ofconstruction or process steps set forth in the following description.The invention is capable of other embodiments and of being practiced orbeing carried out in various ways.

In this disclosure, a convention is followed wherein the distal end ofthe device is the end closest to a patient and the proximal end of thedevice is the end away from the patient and closest to a practitioner.

The term “deformable” refers to a wall or container that is structuredto be flexible enough to collapse at least partially into the innerchamber under manual depression. The shape and extent of the deformationwill vary with the various configurations of the inner chamber anddeformable container.

As used herein, the term “luer” with respect to a connector, connectionor tip refers to a connection collar that is the standard way ofattaching syringes, catheters, hubbed needles, IV tubes, etc. to eachother. The luer connection consists of male and female interlockingtubes, slightly tapered to hold together better with even just a simplepressure/twist fit. Luer connectors can optionally include an additionalouter rim of threading, allowing them to be more secure. The luerconnector male end is generally associated with a flush assembly and caninterlock and connect to the female end located on a vascular accessdevice (VAD). A luer connector comprises a distal end, a proximal end,an irregularly shaped outer wall, a profiled center passageway for fluidcommunication from the chamber of the barrel of a syringe to the hub ofa VAD. A luer connector also has a distal end channel that releasablyattaches the luer connector to the hub of a VAD, and a proximal endchannel that releasably attaches the luer connector to the barrel of asyringe.

The term “priming” is defined as the removal of one or more air bubbles.In the present invention, the volume of the collapsible priming elementmatches or exceeds the volume of the air bubbles within the device. Allregions of the device collapse to minimize dead space remaining in thedelivery device after use.

One application where a primer element is be useful is that of a deviceprefilled with saline or medication and intended for direct connectionwith a vascular access device (VAD). This type of pre-filled deviceoften requires the incorporation of one or more air bubbles within theinternal volume of the container. It is crucial that these devicescontain no air when connected to the VAD. Therefore a priming step mustbe incorporated into the workflow prior to attachment to the VAD.

The present invention overcomes problems associated with known fluidadministration devices and flush devices by providing a single usepre-filled delivery device that effectively removes air and/or solutionfrom a closed container in a step called “priming”. This priming step isachieved through a collapsible deformable container and primer elementas described below.

A single use sterile delivery device overcomes problems found with theprior art by reducing the risk associated with contamination due tomanually filling a syringe with solution from a vial. Other advantagesof this invention over prior art include the following: a) the device ofthe present invention is capable of a generating a secure connectionwith a receiving needleless female vascular access connector and b) thesingle use sterile delivery device of the present invention incorporatesa deformable and collapsible feature capable of displacing a volumecomparable to the volume of the contained air bubbles allows the syringeto be primed prior to use.

The single use pre-filled delivery device of the present invention isshown in FIGS. 1-5. A single use sterile delivery device of the presentinvention reduces the risk associated with contamination due to manualfilling a syringe with flush solution, drug or medicament from a vial.Generally speaking, the single use device of the present inventioncapable of delivering sterile solution to the female luer connection ofa VAD. In general, the device comprises a deformable container capableof holding between 0.5 mL and 10 mL of sterile.

Referring to FIG. 1, a single use pre-filled delivery device 10according to the present invention generally comprises a manuallydeformable container 20 including a side wall 21 having an insidesurface 22 defining a chamber 23 for retaining fluid, and a primerelement 30 for removing one or more air bubbles from the chamber 23. Thedeformable container 20 further comprises a closed proximal end 24, abody 25 and an open distal end 26 including a tip 27 having a passageway28 therethrough providing fluid communication with the chamber 23. Thus,the delivery device 10 of the present invention is capable of agenerating a secure connection with a receiving needleless femalevascular access connector. The tip 27 of the deformable container 20 mayincludes a male luer connector that enables secure connection to thefemale luer connector within a VAD. The vascular access device may be asyringe, extension set, intravenous set, stop cock, tubing, highpressure extension tubing, or needleless connector.

The primer element 30 is attached to and in fluid communication with thedeformable container 20. The primer element 30 may be assembled into thebody 25 of the container 20 or it may be molded into the body 25 of thecontainer 20. The primer element 30 may be positioned on the proximalend 24 of the container 20.

In the present invention, the volume of the collapsible priming elementmatches or exceeds the volume of the air bubbles within the device. Allregions of the device collapse to minimize dead space remaining in thedelivery device after use.

As shown in FIG. 1, the primer element 30 may be in the form of acollapsible button which is convex prior to the primer being manuallydepressed in the direction shown by arrow “A” and is concave after theprimer is manually depressed. As shown in FIG. 1, a convex shape ismolded into the surface of the deformable container 20. Activation orpriming is achieved by depressing on the convex surface to create aconcave surface. The primer element 30 when activated, displaces aspecific volume within the container. The displaced volume matches orexceeds the volume of the air bubbles initially contained within thechamber 23 of the container 20. The primer element 30 may be eithermolded or assembled in the body of the deformable container 20. Acontainer 20 containing both air and liquid may be positioned such thatthe air is located in the region of the open distal end 26 of container20 and the liquid is positioned away from the outlet. The primer element30 may be positioned away from the open distal end 26 of container 20,such that when activated, the button preferentially expels air overliquid.

As shown in FIGS. 2 and 3, the primer element 30 may include a thumbpress 31 located at the proximal end 24 of the container 20 which may bemanually depressed in the direction shown by arrow “A”. As shown inFIGS. 3-17, the body 25 of the container 20 may comprise a plurality ofcollapsible funnel-shaped, concentrically-arranged side walls, whereinthe diameters of the concentrically-arranged walls decrease from thedistal end 26 to the proximal end 24 of the liquid container 20. Theshape of the body of the deformable container allows a portion of thedevice 10 to fold in onto its self, displacing a prescribed portion ofthe contents of the inner chamber 23 and matching the volume required toprime the syringe.

In an alternate embodiment, the primer element 30 includes a thumb press31 located at the proximal end 24 of the container 20 and the body 25 ofthe container 20 comprises a plurality of collapsible funnel-shaped,nonconcentrically-arranged side walls, wherein the diameters of thenonconcentrically-arranged walls decrease from the distal end 26 to theproximal end 24 of the liquid container 20.

Another embodiment of the present invention is directed to a single usedelivery device 10 including a manually deformable liquid container 20defining two or more inner chambers 23, the container 20 having a distalend 26, a proximal end 24, and an outlet on the distal end 26; a tip 27projecting from the outlet on the distal end 26 of the container 20, thetip 27 in fluid communication with the inner chamber 23 of the container20; a primer element 30 for collapsing a portion of the deformablecontainer 20 for driving air out of said chamber 23 by depressing theprimer element 30, said primer element 30 being attached to thedeformable container 20. As shown in FIGS. 18-25, the primer element 30may be in the form of a series of two or more adjoining collapsiblebuttons in fluid communication to the luer end. The two or moreadjoining collapsible buttons may be connected to the luer end either inseries or in parallel, as shown in FIGS. 18-25. The two or moreadjoining collapsible buttons are activated by pressing down in thedirection shown by arrow “A” on the convex surface to collapse thevolume within and expelling the remaining contents from the luer end.When the device is held with the luer end at the highest point, the oneor more air bubbles will move to the luer end. In this position,collapsing the two or more adjoining collapsible buttons will expel airfrom the device such that the remaining inner volume of the device comesin contact with the fluid.

In one or more embodiments, the single use delivery device 10 includes apre-selected amount of fluid in the chamber 23.

The deformable container 20 may be made of thermoplastic elastomers.

As shown in FIG. 26, another embodiment of the present invention isdirected to a single use delivery device 10 including a manuallydeformable liquid container 20 defining one or more inner chambers 23,the container 20 having a distal end 26, a proximal end 24, and anoutlet on the distal end 26; a tip 27 projecting from the outlet on thedistal end 26 of the container 20, the tip 27 in fluid communicationwith the inner chamber 23 of the container 20; a primer element 30 forcollapsing a portion of the deformable container 20 for driving air outof said chamber 23 by depressing the primer element 30 in the directionshown by arrow “A”, said primer element 30 being attached to thedeformable container 20; and a one-way valve 55 disposed between the tip27 and the deformable container 20, the one-way valve in fluidcommunication with the inner chamber 23 of the container 20, saidone-way valve permitting air or fluid evacuation from the inner chamber23 but preventing air or fluid intake into the inner chamber 23 when thecontainer 20 is manually deformed and released. Another embodimentincorporates one way valves at connection points between individualchambers or between the chambers and the luer end. The one-way valve maybe a duckbill valve, an umbrella valve, a ball-check valve, diaphragmcheck valve, swing check valve, stop-check valve, lift-check valve or acombination thereof. The use of incorporated valves reduces flow backinto the device from the luer connection point. This feature reducesreflux in the VAD path generated by back pressure within the syringe. Anincorporated valve may also be used to reduce flow between chambers. Oneexample is a case where a valve is positioned between a chamber used toprime the syringe and a chamber containing the intended contents fordelivery.

Another embodiments of the present invention is directed to a method ofdelivery fluid to a vascular access device comprising providing a singleuse delivery device 10 having a manually deformable liquid container 20defining an inner chamber 23, the container 20 having a distal end 26, abody 25, a proximal end 24, and an outlet on the distal end 26; a tip 27projecting from the outlet on the distal end 26 of the container 20, thetip 27 in fluid communication with the inner chamber 23 of the container20; and a primer element 30 for removing one or more air bubbles fromthe chamber 23, said primer element 30 being attached to and in fluidcommunication with the deformable container 20; providing a vascularaccess device having a proximal end, a distal end, and a passagewaytherethrough, the proximal end having a female luer tip in fluidcommunication with the passageway; placing the distal end of thevascular access device in a blood vessel of a patient; depressing theprimer element 30 to evacuate air within the chamber 23; engaging themale tip 27 of the container 20 with the female tip of the vascularaccess device; applying force to deform the container 20 so that asolution located in the chamber 23 flows through the one-way valve intothe vascular access device; and disengaging the male tip 27 of thecontainer 20 from the female tip of the vascular access device.

The one-way valve prevents reflux of solution in the passageway 28. Theone-way valve may be a duckbill valve, an umbrella valve, a ball-checkvalve, diaphragm check valve, swing check valve, stop-check valve,lift-check valve or a combination thereof.

The delivery device 10 of the present invention may be used inconjunction with a vascular access device having a proximal end, adistal end and a passageway 28 therethrough, said proximal end having afemale luer tip in fluid communication with said passageway 28. To usethe delivery device 10 in a flushing procedure or to administer a fluid,the user engages the male luer tip 27 of the deformable container 20 ofthe delivery device 10 with the female luer tip of a vascular accessdevice, after the distal end of said vascular access device has beenplaced in a blood vessel of a patient. The vascular access deviceincludes a proximal end, a distal end, and a passageway therethrough,the proximal end having a female luer tip in fluid communication withthe passageway. The user then depresses the primer element 30 toevacuate air within the chamber 23. The user applies force to the bodyof the deformable container to collapse the container 20 so that asolution located in the chamber 23 flows through the one-way valve intothe vascular access device. After the expulsion of the desired amount offluid from the chamber 23, the user disengages the male luer connectorof the container 20 from the female luer of the vascular access device.

In one or more embodiments, the single use pre-filled delivery device 10further includes a tip cap that is releasably connected to the male luertip 27 of the deformable container 20 for sealing the passageway 28.

In one or more embodiments, the vascular access device is a syringe,extension set, intravenous set, stop cock, tubing, high pressureextension tubing, or needleless connector.

In one or more embodiments, the single use pre-filled delivery device 10further includes a pre-selected amount of fluid in the chamber 23. Thepre-selected amount of fluid in the chamber 23 may be from 0.5 ml to 10ml. In one or more embodiments, the fluid may include a flush solution,drug or a medicament. The flush solution may be any solution intendedfor flushing or maintaining performance of VAD's. The flush solution maybe selected from the group consisting of saline solution, water, heparinsolution or a combination thereof. These solutions are known in the artand are readily available. The single-use pre-filled delivery device 10may be pre-filled with flush solution, drug or medicament during orafter the assembly of the syringe using sterile filling methods. Suchprefilled assemblies may be supplied with a tip cap 45 that seals thepassageway 28 of the deformable container 20 and male luer tip 27. Thetip cap may be is formed of material selected from a group ofthermoplastic materials and elastomeric materials such as natural andsynthetic rubber, thermoplastic elastomers, combinations thereof, orother easily disposable and/or recyclable material. Once assembled, thesyringe assembly may be used in flushing or administering a fluid to aVAD such as a catheter of an I.V. set.

The materials for the deformable container 20 will have to be chosenbased not only on performance but on compatibility with the injectableliquid. In a preferred embodiment the single use pre-filled deliverydevice 10 is prefilled with injectable liquid. There may be asubstantial amount of time between when the flush assembly is filled andwhen the contents of the flush assembly are delivered. Accordingly,materials chosen for single use pre-filled delivery device 10 may haveto be stable under long term storage.

The deformable container 20, tip 27 and primer element 30 may be made ofthermoplastic elastomers, natural rubber, synthetic rubber,thermoplastic materials, or other easily disposable and/or recyclablematerial and combinations thereof. Thermoplastic elastomers include, butare not limited to, polypropylene, polyethylene and the like. Materialsshould be chosen to be compatible with the solution, medicament andmanufacturing process being used. It is envisioned that in one or moreembodiments, the delivery device 10 of the present invention may be madeof a single material to facilitate recycling of the device.

In one or more embodiments, the delivery device 10 further includes atleast one protrusion on the primer element 30 for removing one or moreair bubbles from the single use pre-filled delivery device 10 andcontrolling the delivery of fluid from the delivery device 10.

The single use pre-filled delivery device 10 of the present inventionmay be manufactured in accordance with a blow-fill-seal technique of acharacter well understood by those skilled in the art.

The concept of a blow-fill-seal process is that a container is formed,filled, and sealed as a unitary container in a continuous manner withouthuman intervention in a sterile, enclosed area inside a machine.Blow-fill-seal manufacturing forms a closed container by extruding andforming a parison within a mold, filling the container and sealing thecontainer in a single step. This manufacturing process enables thedevice to be produced in a single process. For example, pharmaceuticalgrade resin is extruded into a tube, which is then formed into acontainer. A mandrel is inserted into the newly formed container andfilled. The container is then sealed, all inside a sterile, shroudedchamber. The product is then discharged to a non-sterile area forpackaging and distribution. This blow-fill-seal technique comprises thecontinuous extrusion through an extruder head of a length of a parisonin the form of a hollow tube between and through two co-acting first ormain mold halves. The method includes the step of cutting off theparison below the extruder head and above the main mold halves to createan opening which allows a blowing and filling nozzle assembly to bemoved downwardly into the opening in the parison for molding andthereafter filling a molded container. When the container portion of thecontainer assembly is filled with the desired amount of liquid, theblowing and filling nozzle assembly is retracted from the opening in theparison. A separate pair of co-acting second or upper sealing moldhalves are then moved together around the exposed length of parison toform and seal the container upper portion. The finished containerassembly, completely formed, filled, and sealed as a unitary structureis then conveyed out of the molding apparatus.

A single use pre-filled delivery device 10 of the present inventionreduces the risk associated with contamination due to manual filling asyringe with flush solution, drug or medicament from a vial.

Reference throughout this specification to “one embodiment,” “certainembodiments,” “one or more embodiments” or “an embodiment” means that aparticular feature, structure, material, or characteristic described inconnection with the embodiment is included in at least one embodiment ofthe invention. Thus, the appearances of the phrases such as “in one ormore embodiments,” “in certain embodiments,” “in one embodiment” or “inan embodiment” in various places throughout this specification are notnecessarily referring to the same embodiment of the invention.Furthermore, the particular features, structures, materials, orcharacteristics may be combined in any suitable manner in one or moreembodiments.

Although the invention herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent invention. It will be apparent to those skilled in the art thatvarious modifications and variations can be made to the method andapparatus of the present invention without departing from the spirit andscope of the invention. Thus, it is intended that the present inventioninclude modifications and variations that are within the scope of theappended claims and their equivalents.

What is claimed is:
 1. A single use delivery device comprising: amanually deformable liquid container defining an inner chamber, thecontainer having a distal end, a body, a proximal end, and an outlet onthe distal end; a tip projecting from the outlet on the distal end ofthe container, the tip in fluid communication with the inner chamber ofthe container; and a primer element for removing one or more air bubblesfrom the chamber, said primer element being attached to and in fluidcommunication with the deformable container.
 2. The single use deliverydevice of claim 1, wherein the primer element is assembled into the bodyof the container.
 3. The single use delivery device of claim 1, whereinthe primer element is molded into the body of the container.
 4. Thesingle use delivery device of claim 1, wherein the primer element ispositioned on the proximal end of the container.
 5. The single usedelivery device of claim 1, wherein the primer element is in the form ofa collapsible button.
 6. The single use delivery device of claim 5,wherein the button is convex prior to the primer being manuallydepressed.
 7. The single use delivery device of claim 5, wherein thebutton is concave after the primer is manually depressed.
 8. The singleuse delivery device of claim 1, wherein the primer element comprises athumb press located at the proximal end of the container and the body ofthe container comprises a plurality of collapsible funnel-shaped,concentrically-arranged side walls, wherein the diameters of theconcentrically-arranged walls decrease from the distal end to theproximal end of the liquid container.
 9. The single use delivery deviceof claim 1, wherein the primer element comprises a thumb press locatedat the proximal end of the container and the body of the containercomprises a plurality of collapsible funnel-shaped,nonconcentrically-arranged side walls, wherein the diameters of thenonconcentrically-arranged walls decrease from the distal end to theproximal end of the liquid container.
 10. The single use delivery deviceof claim 1, wherein the primer element is in the form of a series of twoor more adjoining collapsible buttons in fluid communication.
 11. Thesingle use delivery device of claim 1, wherein the tip is releasablyengageable to a vascular access device.
 12. The single use deliverydevice of claim 1, wherein the vascular access device is a syringe,extension set, intravenous set, stop cock, tubing, high pressureextension tubing, or needleless connector.
 13. The single use deliverydevice of claim 1, further comprising a pre-selected amount of fluid inthe chamber.
 14. The single use delivery device of claim 1, wherein thedeformable container is made of thermoplastic elastomers.
 15. A methodof delivery fluid to a vascular access device comprising: providing asingle use delivery device having a manually deformable liquid containerdefining an inner chamber, the container having a distal end, a body, aproximal end, and an outlet on the distal end; a tip projecting from theoutlet on the distal end of the container, the tip in fluidcommunication with the inner chamber of the container; and a primerelement for removing one or more air bubbles from the chamber, saidprimer element being attached to and in fluid communication with thedeformable container; providing a vascular access device having aproximal end, a distal end, and a passageway therethrough, the proximalend having a female luer tip in fluid communication with the passageway;placing the distal end of the vascular access device in a blood vesselof a patient; depressing the primer element to evacuate air within thechamber; engaging the male tip of the container with the female tip ofthe vascular access device; applying force to deform the container sothat a solution located in the chamber flows through the one-way valveinto the vascular access device; and disengaging the male tip of thecontainer from the female tip of the vascular access device.
 16. Asingle use delivery device comprising: a manually deformable liquidcontainer defining an inner chamber, the container having a distal end,a proximal end, and an outlet on the distal end; a tip projecting fromthe outlet on the distal end of the container, the tip in fluidcommunication with the inner chamber of the container; a primer elementfor collapsing a portion of the deformable container for driving air outof said chamber by depressing the primer element, said primer elementbeing attached to the deformable container; and a one-way valve disposedbetween the tip and the deformable container, the one-way valve in fluidcommunication with the inner chamber of the container, said one-wayvalve permitting air or fluid evacuation from the inner chamber butpreventing air or fluid intake into the inner chamber when the containeris manually deformed and released.
 17. The single use delivery device ofclaim 16, wherein the one-way valve prevents reflux of solution in thepassageway.
 18. The single use delivery device of claim 16, wherein theone-way valve is a duckbill valve, an umbrella valve, a ball-checkvalve, diaphragm check valve, swing check valve, stop-check valve,lift-check valve or a combination thereof.
 19. The single use deliverydevice of claim 18, wherein the one-way valve is a duckbill valve. 20.The single use delivery device of claim 18, wherein the one-way valve isan umbrella valve.
 21. A method of delivery fluid to a vascular accessdevice comprising: providing a single use delivery device having amanually deformable liquid container defining an inner chamber, thecontainer having a distal end, a proximal end, and an outlet on thedistal end; a tip projecting from the outlet on the distal end of thecontainer, the tip in fluid communication with the inner chamber of thecontainer; a primer element for collapsing a portion of the deformablecontainer for driving air out of said chamber by depressing the primerelement, said primer element being attached to the deformable container;and a one-way valve disposed between the tip and the deformablecontainer, the one-way valve in fluid communication with the innerchamber of the container, said one-way valve permitting air or fluidevacuation from the inner chamber but preventing air or fluid intakeinto the inner chamber when the container is manually deformed andreleased; providing a vascular access device having a proximal end, adistal end, and a passageway therethrough, the proximal end having afemale luer tip in fluid communication with the passageway; placing thedistal end of the vascular access device in a blood vessel of a patient;depressing the primer element to evacuate air within the chamber;engaging the male luer connector of the container with the female luerof the vascular access device; applying force to deform the container sothat a solution located in the chamber flows through the one-way valveinto the vascular access device; and disengaging the male luer connectorof the container from the female luer of the vascular access device.